[Music] good afternoon everyone and good morning to our friends joining us from both the i believe the mountain in pacific time zones my name is michael lipinski and i'll be one of your speakers today for this webinar and uh as folks are joining us i have been thinking that since we have multiple time zones i'm trying to figure out if there's good morning or good afternoon and and that uh you know we just recently last week switched to uh standard time everyone um i thought maybe we could start with an icebreaker by uh pulling the audience on the value of daylight saving time and uh which is better daylight saving time or standard time but i'm just kidding we have a much more exciting topic to cover information blocking but really the exciting topic is information sharing and that's what the information blocking regulations really do they enable information sharing and we'll go through that today how that can occur uh through through the provisions of information blocking so today is the second webinar in our series of webinars designed to help one particular set of actors health care providers better understand the information blocking regulations but you know please wait if you're not one of them and there's actually a fact sheet on our website to help you to determine if you're a health care provider um but even if you're not one of them after you look at that fact sheet please don't disconnect from this webinar the information we're going to provide today will be helpful to all those subject to the information blocking regulation which would be developers of certified health i.t health information networks health information exchanges as well as those who that aren't subject to it but can benefit from the information blocking regulations and honestly um many of those that are subject to the information blocking regulation we'll talk a little bit about this as all well today are going to benefit from the regulations you know for example small physician practice groups and so i just want to start with the refresher the purpose of these webinars is to provide an overview of information blocking also to highlight key considerations for actors covered by information blocking it's also to what i'll call address issues of the day so that could be whether we've issued recent frequently asked questions uh or other educational resources or we've received some recent questions from stakeholders that we wanted to respond to uh via broader audience and then as always um these webinars will help highlight the benefits of information sharing as supported by the information blocking regulations so again as i mentioned it's the second webinar the first was the overview of information blocking essentially like a 101 it was held on september 14th and the recording is available on our website with the slides uh today you can you can find them and then today's webinar is actually uh part one of multiple webinars that will cover the information blocking exceptions it is uh you may have got a notice already if you've joined us that the webinar will be recorded we will not be taking live questions but you're welcome to submit questions through the q a feature which is enabled for this presentation we're going to do our best during the webinar we have some colleagues on who will try to answer your questions through the q a however i do want to mention that we will have another ask onc about information sharing on december 10th so you can join that it was we first held one on september 24th and it was both well attended and beneficial to those who attended based on the feedback we received so i encourage you to attend uh that q a um you know ask owen c session uh if possible so uh with that let's move to the next slide okay so as an attorney i have told uh folks that it would be fine to put this material in four point font and and just move on but uh since they didn't listen to me uh you can read everything uh here for yourself on this slide i think the uh main takeaway is we're going to try our best today to present accurate information but sometimes we misspeak so please remember the official provisions and requirements are found in 45 cfr part 171 next slide please so i'm on the right there and i'm going to be joined today shortly by my steam colleague dr tom keane to help me present today's material and probably inevitably scold me for either using legal terms or something overly vague or non-committal but in all seriousness i personally want to thank tom for the perspective perspective and expertise he provides that helps all of us here at onc better convey the information blocking goals and expectations to our healthcare provider community and really to to all stakeholders and in this regard i thought it was appropriate or we thought it was appropriate to recognize the whole clinical team that contributes to this effort so next slide please so my colleagues listed on this slide led by dr tom mason have been constantly engaging with clinicians in the healthcare provider community to get better sense of the issues you are facing when implementing the information blocking regulations and we wanted to acknowledge their efforts and more importantly let you clinicians know that your perspectives concerns and questions are being both represented by these clinicians and also brought back by them to onc for full consideration and with that i'd like to turn it over to our national coordinator mickey tripathi for some introductory remarks before we dive into the details of today's webinar mickey great thanks mike and welcome everyone thank you so much for joining um i just uh we're deeply appreciated appreciative that all of you have joined and um i'm going to be brief but just want to cover some highlights about uh the information sharing regulations that come from the 21st century cures act and um and then really just welcome you and turn it over to uh to to mike and the team um i information sharing is really important i think as all of us know uh the cures act um from which everything that we're gonna talk about derives uh was passed in 2016 with uh immense bipartisan support as well as widespread support from the healthcare community i think as we know information sharing promotes better more coordinated care by ensuring complete and up-to-date information that's readily available and when health data is stored electronically clinicians are right to expect to be able to access that data when they need it from other conditions from other clinicians and others who are participating in the care of their patients the information sharing regulations i think also empower clinicians to be able to strengthen the ability of patients to participate directly in their in their own care which as we know is the driver of better health outcomes and to help patients better understand how to be able to access their own information to be able to participate more directly in their care as well so i think that that you know from the information sharing provisions there's you know there's a lot of good um that comes from that and we want to be able to um get that going as quickly as possible so they can get the benefits on behalf of uh patients as well as providers who are providing that care the health care is the most complex part of the economy i mean bar none it is unbelievably fragmented it is highly complex and just medical care itself is highly complex because individuals are highly complex and medicine is ever evolving and um and and uh and you know and it's just a highly complex endeavor um in general and so that means that you know we wanted to make sure um and the law does this and the onc regulations do this we want to make sure that there is flexibility to accommodate individual circumstances because we recognize that um that healthcare varies tremendously across the country um it varies by setting it varies geographically it then it varies by uh by patient population um and so there's a tremendous amount of heterogeneity and that's why the rules very explicitly allow for exceptions there are eight exceptions that we'll describe in further detail that uh provides some you know reasonable practices um that allow the flexibility where um where it may not be appropriate to share information um and those exceptions build in flexibility to accommodate that wide range of systems and circumstances which clinicians and other healthcare providers use to you know to serve your patients um furthermore the um the enforcement part of this is case by case by design it's case by case again um you know making uh you know sort of clear and recognizing that individual circumstances matter um in health care in particular individual circumstances matter because every single situation is different um so we just want to you know make sure that you have a full understanding of the flexibility that is baked into these regulations and and you um have a very good understanding of how to apply those appropriately and that's what a lot of you know sort of all the information and education outreach um they were doing is geared toward helping you as clinicians and providers have a better understanding of that one of the things that i wanted to just talk about in closing before before turning it back over to the team is again just to thank you in advance for joining the webinar today and and i really really hope that it's going to be useful to you we're going to be covering faqs as well as other information and you know this process that we're in um which is you know all the various channels that we have for communicating with you know with all the stakeholders about the regulations is you know is is very much a bug i mean a feature and not a bug of the process precisely because of what just what i described before that health care is unbelievably complex and so um these regulations um you know are regulations that we want to be able to uh continuously have discussions and to understand the difficulties understand problems that uh that you may be encountering in interpreting different things or where we can clarify things um to be able to uh you know provide that kind of clarity so you have a better understanding of it um and you know that's a as i said is very much a feature of the regulatory process in the u.s it's not a bug of the process so we very much welcome your engagement and your further engagement um you know your questions and comments um and concerns are you know what help us um provide you with better information um so we also try to be extremely extremely responsive to your questions um with to the best of our abilities and we work really really hard um to you know to do that and everyone you know who's listed in that slide before the clinical team and the the regulatory team um you know does a tremendous amount of work to be as responsive as as we can um i do you know want to make sure that you have an understanding of what is behind that um you know process every single faq that we get every every single thing that you're going to see today and in everything that we put out is not only you know sort of vetted within onc by all the onc specialists as well as lawyers we've got plenty of lawyers in the onc staff but it's also reviewed by the hhs office general counsel it's reviewed by the hhs office of inspector general and as applicable it's reviewed by the hhs office of civil rights um which uh which uh regulates hipaa so there is a you know a process that we go through for every single um piece of information that we um put out to market so you know that's that's one of the constraints but also one of the benefits i think of the information that uh that you end up seeing is that it's been through a process of making sure that what we're saying and what we're putting out is aligned with the law um and is consistent with what the law and the regulations allow um and then we do we take the further step as best as we can to try to put this in plain english terms as well and that's perhaps the hardest the hardest thing that we try to do here so we want to make sure i mean it's obviously got to be accurate this is compliance after all these are real regulations and compliance is very important so compliance officers and lawyers have to be able to understand it um but it's also very important to do everything we can to make um the to communicate in an intuitive plain english way as well so you know we try very hard to do that as well i'm sure that we don't hit the mark um as often as we'd like on that on that score um and we very much welcome your feedback so you know we're always trying to do better um please let us know if you find this useful um if you have any feedback for us on how we can communicate better because as i said we're always striving to do to do better and working very hard at it so um thank you again in advance for your participation this webinar and uh let me turn it back to mike and the team uh thank you mickey um all right let's uh move on to the next slide and jump in so um with these first uh two slides we're going to take a step back in a sense um and uh quickly over what the cures act provided related to information blocking and then also on the next slide the information blocking definition and we're doing this since this today's presentation isn't going to be a 101 um this these slides will hopefully give you all a foundation for the more discreet topics we are going to discuss today and um going back to one point that mickey made um because i i looked this up last night actually um about the cures act being overwhelmingly bar bipartisan legislation so at the time it was a uh a republican congress and when we would say um overwhelmingly it was uh in the house the vote was 392 to 26 in favor of the legislation and in the senate it was 94 to 5 with one abstaining and then it was signed into law by president obama on december 13 2016.
So for me personally i take pride and it's a privilege to have the ability to implement these statutory provisions so we can move to the next slide so again as a foundation here is the definition in the regulations of information blocking we're going to hit on some of these topics particularly ehi and then obviously the um exceptions what you should take uh from this slido is you know the box on the right which is the elements of information blocking uh to know that um you know generally what they all are um and that uh it's not and we'll talk more about um like i said some of the exceptions in ehi the one thing looking at those elements remind me that i should mention just i think it was yesterday um we released a blog from our deputy national coordinator steve posnak and that's going to be one of the ways that mickey mentioned that we're going to communicate to you and that blog focused on how the intersection of other laws with information blocking and how that relates either to require by law how it relates to whether or not you know there's an interference and even whether you know an exception could apply so i encourage you to read that blog and again there'll be um more blogs in the future on topics related to to information blocking so let's move to the next slide so i'm just going to read actually from this slide and to to emphasize what we're going to go over today so we're going to talk about um what we call exceptions which in the statute as as you saw are reasonable and necessary activities that need to be uh identified by the secretary that would not constitute information blocking uh we'll use a we're going to kind of use a q a approach uh like with my colleague dr uh keen about how you may how an exception may apply under circumstance and uh we'll rely on some of those faqs we just issued um eventually once we get through that and uh a discussion of um ehi as well uh we'll talk about um a couple of common misconceptions that we've heard and tried to address through through um faqs and then tom's gonna talk to you more about one of the the key point about about the regulations was um you know why information sharing matters and and how how can we utilize this this regulation to achieve it um and then lastly i'm going to come back and and talk to you a bit about how to report a claim of information marketing or ask a question and then how we initially process those claims when they come in and then lastly i will talk about where to find a lot of this information and and then when you know more will be coming out and and so forth so uh with that let's uh let's jump jump into some more of the substantive content so next slide please okay uh so a lot of this is pulling information from what's called the preamble of our rules so uh from the final rule and even the proposed rule that established the information blocking regulations so um and you'll see this on the next slide but these are generally the goal how they fit how the exceptions fit that is on the next slide but on the left here you have what generally are were the goals we were trying to achieve with the exceptions so that's confidence in the health it infrastructure so that's you know protecting privacy and security of each eye and uh patient safety um there are other ones with uh the actual infrastructure itself an exception that focuses on that we also wanted to promote competition and innovation so there are exceptions that focus on that and then being onc we obviously wanted to focus on standardization and interoperability of ehi and so then when we had those goals what we did with the exceptions and again this is a little bit foundational is we tried to make sure we put parameters which generally are called conditions in the exceptions uh to make sure that there were guard rails in how they were used and they were used for that specific purpose so like narrowly focused uh focused on that actual topic to use the exception whether it's privacy or security um use uh certain terms about characterizing the risk and um other things that you'll hear a lot throughout when we start talking about like being non-discriminatory and using objective criteria things of that nature to make sure that um the exceptions weren't abused and were used in a way that was pretextual for for a way to block information so let's jump to the next slide and so now i'm quickly like i think having talked through that you can see where like obviously there's a specific privacy and security and harm exception and those are going to fit under that health it infrastructure so does the health it performance exception uh your fees and licensing exceptions fit under the innovation and competition one and then you have like your for example your content and manner exception that's uh highly focused on a standardized approach uh and inoperability in making ehi available um i think you know um the other thing that i would want to um draw your attention to uh are two things one the ones in red will be the ones or a burnt orange i don't know what it is red i think um those are the ones we're gonna try to talk to about today and we're not going to talk about them in detail like every single provision and every condition and every um you know requirement we're going to try to like i said do it through a q a of when one might be the appropriate one or the intent behind when you would use that that exception um the other thing you should notice here is the exceptions kind of fall in two categories the first category on your left are where you're going to be using deception not to provide any access exchanger use and then on your right are categories where you're going to actually be providing vhi but under certain conditions and with that let's jump to the next slide another bit of a disclaimer here uh like i said there'll be real world examples via questions and really um what you need to take away from this slide uh besides the fact that at the very bottom there uh it identifies who are actors and their definitions for actors uh in the regan and discussed in other slides um and i mentioned the fact sheet you can look at for a healthcare provider as well that's on our website but what you really need to take away from this is info blocking has was set up to be assessed on a case-by-case fact specific basis uh and you'll see that disclaimer on some of the other slides as well so and we're really not in a position to have all the facts to to give a definitive answer nor are we in a position to opine on whether something constitutes information blocking even under a full set of facts however i think what you need to know and um this is gonna there's a correlated point also on the next slide about this is um if even if you don't meet an exception it doesn't mean you're you've committed information blocking so um let's go to the next slide for two important points as well so that one is like i just said the filler meet exception doesn't mean that you um have committed any information blocking and and that's what i've been trying to point out as we've gone through so far there are elements to information blocking beyond whether or not you made an exception so for example uh you need to have the requisite knowledge and so if you're a healthcare provider that means uh you have to know two things you have to know that it was an interference so that means it um it interfered with uh materially discouraged uh or prevented access exchange of use and you had to know that that was unreasonable your practice so you need to know that and then whatever you did your practice actually has to rise to the level that meets uh the definition of an interference under under the regulations so please keep that in mind the other uh point worth mentioning is um it's important to document if you're going to take an exception we mentioned that throughout the rule but we don't we don't specify a form or format how you do that we've we've really left it up to the actors as to how much they feel they need to document and how they document that so please uh keep that in mind as well and uh with that i think we're gonna start talking about the exceptions and let's move there okay yeah so i'm gonna jump in here my my name again to introduce myself as tom keane before i came into government i had been a practicing interventional radiologist for more than a decade and today in the q a between mike and i i am going to play the role of the doctor and mike is going to play the role of the lawyer and i'm very excited that for once the shoe is on the other foot and a doctor gets to pepper a lawyer with questions i my boss has turned down my request that i get paid 400 an hour for doing so but i am still going to make the most of this so my first question to you mike is if a patient requests their electronic health information is it sufficient to provide them with a pdf copy well tom when is it sufficient uh well um in a very lawyerly response i'm going to say it depends but actually i'm going to give you a lot more than that in terms of response here um but i do want to mention you know again on the right there you'll see some key points and provisions about this exception right so the pdf question that you've just asked comes into play if you don't you don't either technically are unable to provide the ehi in the way that they've requested it or you couldn't reach agreeable terms because we've established this exception to allow for like uh access to ehi exchanging use of it on market terms and if that can happen we set up an alternative manner approach and so your question comes into play when you're in the alternative manner which has an order of priority and i alluded to earlier is the standard you know focusing on standards for certified health i.t then on standards and ultimately uh on what is called a machine readable format if uh neither the other ways could be provided um they also the other thing that i think sometimes gets lost with this exception i've seen is it has to be agreed to by the res the requester so we're gonna take in this instance that the requester did say i wanted it in uh pdf and and that's how we got to this point and for for the pdf to be appropriate under this exception it should be interpretable um is really and it should be um essentially machine readable output right so for some pdf that's not going to be the case uh for example ehis as images all right those uh generally might not be interpretable or machine readable output but what i can say is one way a pdf could be machine readable format would be if it was structured so that data is conveyed the data conveyed it could be consumed by another software program would be using consistent processing logic and that would be consistent with nist or the national institute for standards technology definition of machine readable um so if you're going the pdf route i i would strongly encourage you to keep that in mind that it really needs to be interpretable and in a machine readable output and normally images aren't going to meet that standard okay mike thanks that's a question we hear a lot from providers in the field so i'm going to hit you with another one that we hear a lot if a patient requests ehi in electronic form and i don't have an ehr what does the regulation say about that okay um so just uh for our audience awareness these aren't faq so we've tried to label um the questions that are faqs and they're they're really all the ones we're going to be talking about today that our faqs are new faqs we've just issued in the past couple days but this is a like you said a relevant question um let me quickly go over the infeasibility exception in a very high level it really consists of three conditions um there's incred there's like circumstances we would call in controllable events i'll talk about that last uh there's circumstances where it's a segmentation issue and that's i see your question second question on the screen so that's where we're going to get into that um but this question you've just asked actually implicates the the third part of the infeasibility exception which is in feasibility under circumstances and this exception is you know remember all the exceptions are established to um address all issues for actors so the actors you know we have a broad scope of actors that are covered by information blocking like i mentioned earlier health information networks exchanges developers of certified health i.t and then really the broadest category is healthcare providers which can be providers that are hospitals large hospital systems that are using certified health i.t to small practices in rural areas that in this case with this question don't have an ehr or even long-term post-acute care setting where they don't have um potentially any hr but as this question says if it's ehi so that just means it has to be in electronic format and in in certain cases pdf is at least ehi it may not be machine readable but it is ehi so here really it's a test uh under the circumstances and you're looking at certain factors and these factors are outlined in the in the reg um but they want to look at you know what what type of the hi are we talking about here uh the purpose for which it's needed so is it needed for treatment for example uh what would be the cost to to the actor to comply uh so in this case if i don't have any hr and they're asking it in some type of um uh i don't know an api approach or something or then you know what's the cost of me to try to establish that uh and that includes also whatever financial and technical resources that are available to you and you can see that these factors can be applied into in all the settings i just mentioned you can apply these factors for small healthcare practice or for a large healthcare system and we obviously know that the factors are going to turn differently for them right if it's uh a large health care system in terms of resources and finances but quickly a couple other factors you know they have to be non-discriminatory in how they do this so if they provide this data in a different you know to all their customers or partners but then they're not providing it to this request the pa then that's gonna weigh against them right um and then you know it also looks at what we just talked about content and manner and and why you couldn't have done it through one of those options because if you have the hi maybe you can provide it in a machine readable format but maybe you weren't able to take advantage of that exception because the patient uh in this case wouldn't agree with it so bottom line is this exception is uh has been established to address these type of situations that you raised but it also there isn't a definitive answer based on just the information we have in this question because it looks at a host of factors i just talked about tom okay thanks that's helpful now uh let me go on to a uh another uh real world type situation that we hear a lot about let's say that you have a adolescent patient and she has juvenile diabetes and her parents request the ehi in order to help manage the juvenile diabetes but mixed in with her medical records is information about oral contraceptive pills that she's been prescribed and she would prefer her parents not to know that she's taking oral contraceptive pills and and you're aware of this and there's no way for you to segment out the information on the juvenile diabetes from the information on her reproductive history what do you do in a situation like this what does the regulation prescribe all right so um yeah tom when you first you know mentioned this question i i thought it was a great question because this is probably what um our listeners clinicians healthcare providers are really dealing with on a day-to-day basis a very more complex situation uh could even get more complex as to why uh you know the the patient didn't want to share it right we didn't really doesn't other than we know he doesn't want to uh he or she doesn't want to reveal it we don't really know the the intent behind that um but uh there's an important point already on the screen here and that's that they've in the state they've reached the age of consent so under the which we're not talking about really today but the privacy exception uh it allows an actor not to share ehi um based on uh a patient or individual's wishes right so you're taking that into consideration you're looking this but this patient this adolescent says only certain information i don't want to have shared so that that doesn't necessarily apply to all this information but what we're hearing here is there's no way to electronics segment it and what the infeasibility exception allows for then is that if you can't unin biggestly segment the request of dji from the other you can take advantage of this exception so hopefully that's helpful to folks who may be dealing with this very similar situation i know i've heard it more than once so i'm sure they are um there's not a question on the slide about what i'm about to mention but i've heard it i think others have heard it you know in dealings with stakeholders so i think it's worth mentioning and it's about that third condition the uncontrollable events which uh in legal time terms are sometimes called uh in contracts force major and those are like military acts natural disasters and even public health emergencies so i've received the question oh there's there's a public health emergency right now for the coca-19 pandemic so i'll i can use that uh condition right not to make ehi uh accessible or for use or exchange and that's not quite how it works and i we've tried to highlight a bold font on the screen it has to be due to that public health emergency so you the actor needs to establish a causal connection between why they can't provide it and the public health emergency because as mickey mentioned earlier on like as just as an example um having this information uh drawing like for example immunization records during the public health emergency would have been probably very valuable and we heard that in some comments on our interim uh final role in terms of when we delayed the applicability date of information blocking so i wanted to just uh touch on that quickly because i've heard it and this this seemed like a good opportunity to mention it so tom back to you okay thanks so we've talked about uh in feasibility here let's talk a little bit about fees um so if um one of my patients asked me to provide a copy of his medical record on paper or on a usb device or on a cd um can i charge that patient a fee for the service we hear this quite a bit from the uh the community so um on this one right here this this question i can actually start off by telling you yes under the information blocking regulations and um the information like so just to try to give you a real quick background on how this fees exception works is that we you know interpretation of the uh info blocking definition said that any fee could be an interference but obviously certain fees should be able to be charged in certain situations so we created the fees exception but then we went in very detail about what type of fees could be charged and then what fees could could not be charged for so essentially excluded um and then the patient situation is even more unique um under the the fees exception so as you see in the headline you're probably like okay wait uh reasonable profit margin too that doesn't apply uh to the patient situation so we've got generally the two patient situations on the screen here um one i'm just gonna let you read which is the the not covered one and that's about electronic access but in this case we're talking about um one i just want to confirm and it's in our you know more elaborated on in our our faq but if you're talking about ehi it doesn't matter what form or format they're asking for it you you are within scope of the information blocking regulations so what we've talked about oh in the role is you know both about manual effort and there can be a charge about manual effort but also we uh aligned um this exception with uh the hip hipaa roles in particular uh the hippo privacy's rules individual right of access so i believe that is and again this is why we have our disclaimer i think it's a 45 cfr 164 524 c4 so that that provision lays out what um fees what fees what category of fees can be charged for and so we've essentially said any fees that are beyond those categories would be prohibited under the information blocking regulation what we have in seto um is specify what is actual reasonable fee under this so you know for example i've also heard like is ten dollars okay or that we have not um opined as to that because i think they're that's very you know taking into account what they're charging for have they met the categories but generally speaking as long as you're you know aligning with the hipaa right of access and their reasonable fees you would you would be okay in that sense instance um but if it's not a patient there's again um a lot of specificity both in the reg text and in the preamble discussion of those provisions as to you know what criteria you can use and what fees are excluded so please keep that in mind tom okay mike thanks so we've talked about content and manner and we've talked about in feasibility and we've talked about fees let's talk about the fourth exception that we wanted to discuss today namely licensing so uh the first is an example near and dear to my heart let's say that i'm a rural radiology practice and i get referrals from physicians all over a large catchment area and many of these physicians would like access the ability to see these images and we contain the images on a web-based pac system that we have to pay for and if we want to give seat licenses to the requesting physicians it's going to cost us a fair amount of money for each of these licenses can we charge these physicians for those licenses so that they can go to a website log on and see their patients images so thanks tom for the question um i i'll probably first start by you know uh emphasizing uh the point at the bottom of all these slides that we said would be there which is they're gonna be these cases will be evaluated on a case-by-case basis but we did want to talk about like uh using examples how would this potential exception apply right um so looking at the the facts that we have as as provided in this question um the first thing i would mention is so there's also the content and manner exception right which allows you to get the benefit of the exception um if all parties agree to whatever the license or fee is because the licensing exception and the fees exception don't apply in the circumstance those exceptions only apply if you end up in the alternative manner then you have to be also compliant with the licensing and fees exception but maybe you're thinking in this situation um i don't even want to have to worry about information blocking so if i you know make sure i'm consistent with the licensing exception then no one's going to come back to me and um you know raise a claim of information blocking particularly in this case the the referring physician may be the one who does that right so the cost of the license um what you want to consider here under license so you're allowed to charge a reasonable royalty um for a license uh so you and that includes profit um but there are specific again provisions you know like i'll mention at least one of them like it has to be non-discriminatory and how how you approach this so if you're giving one license to one of these referring positions and you're changing it for other ones that may take you out of the benefit of the the exception the other thing to keep in mind if you're charging other fees the the fees exception and licensing exception um essentially work together so you can't like double charge for the same um i don't know development for example development costs like you you can get charged for it but you you can't double charge it under the fees and then as part of the royalty as well so um so yes you you could you could consider it um there's not a requirement remember to use these exceptions um it's just something that maybe you want to do to give yourself assurances that in that instance it's not going to be information blocking but like i said if there was agreement amongst the parties on market terms you may even qualify for the content of manner exception okay um so let's uh pivot it a little bit let's say that i'm not uh re-licensing somebody else's uh work here let's say that uh my partners and i have built a mobile app that requires an interface to an ehr and the ehr vendor says well you have to license us the source code if you want the app to be able to interface uh with our product can the ehr vendors do this so um this is a good question in terms of like trying to under the broader how to rubric of information blocking so this really isn't a licensing question because the licensing question is for the actor and in this case this could be a uh any app one doing something on behalf of the uh um [Music] covered entity for example and needed to connect to the ehr or it could be on behalf of a patient but in in those cases it's you're not really licensing in our trying to license the interoperability element because that's the interoperability is connected to being needed to access exchanger you see use the ehi what this is more is actually something we talked about in the rule which is uh contract terms and so if the actor here the hr vendor assuming their developer certified health i.t and they're covered by the information blocking regulations we talked about essentially what are called like in in legal speak unconscionable terms um in that this would be one of them if they tried to force them to relinquish ip rights um or even like another example we gave him the role was agreeing to identify the actor for acts beyond like standard practice such as uh gross negligence so those type of provisions and contracts or requests could rise to a level of an interference so um i didn't want to lose this question even though it didn't fall neatly under the licensing exception i thought it was an important question to use for us to emphasize and call out what we said in the rule about you know because this is something we heard a lot through the both the comment period and leading up to even the proposal uh these type of practices that were inhibiting access in exchange of use of dhi so it was a it's a good one to use to come back and emphasize that okay uh if it's all right mike i'd i'd like to pivot a little bit we've talked about contents and manner and feasibility fees and licensing um let's talk uh more generally about what electronic health information is because this is what we're going to be required to share now as i understand it the regulation has provided a a stepwise path towards sharing all electronic health information and that currently only some data elements need to be shared and these data elements are defined in the united states core data set for interoperability or the uscdi at some point in the future i know we're going to have to share it all but currently we're we're sticking with the uscdi so my my question for you is um if we look under this clinical notes section it says one of the things that we currently have to share is a progress note for the purposes of uscdi um what's a progress note yeah thanks thanks for that tom i think it was good that you um talked about you know how you understand it and um hopefully a lot of folks who are listening to have a similar understanding but we will you know tackle that uh with some specificity today uh particularly i heard you say you know soon we're gonna have to share all of it so we're gonna talk about what all of it really is primarily on the next slide but to your first point which is like hey it's like a stepwise approach and that's true we what we did is um beyond just delaying the applicability date we set up the definition where the definition of ehi or at least for the purpose of information blocking uh was limited to the data represented by the uscdi uh from the applicability date which which is april 5th of this year all this way through um october 5th of 2022 but we're only less than a year away and on october 6 2022 it will be that quote unquote all ehi that we'll talk about uh eventually on the next slide but uh for now it is limited to that data represented by the u.s cdi and we have a lot of faqs on our website to talk about like you know it's not you have to use the standards it's really just the elements keep that in mind and but then people are like well you know what is a progress note and actually um and they've asked about other notes too and again there are faqs on the website for example you know a clinical note isn't um limited by the type of specialty or who the author was um so keep that in mind and we have questions about whether you know psychotherapy notes are included which they're not um but we had a question about you know whether draft clinical notes are included and hold that one because we'll talk about it a little bit on the next side uh and there's an faq so you can definitely go to that but the newest faq is the one you i'm getting to it right the newest faq is the one on progress notes and there's actually a definition of what a progress note is in the uscdi uh version one that we what is called incorporate by reference and that is a progress note represents a patient's interval status during a hospitalization outpatient visit treatment with an ltpac provider or other healthcare encounter so any note that meets the above definition is considered progress note for the purposes of the information blocking regulations and i want to just emphasize that part because those developers who certify technology under the program there are different requirements when it comes to meeting the uscdi uh standard um so keep so make sure you're aware of that if if you are a developer certified outside and you have to comply both with certification requirements and information blocking and ultimately uh this definition um will probably move to your to your second question so sure so since since you brought it up uh after the uscdi goes away what constitutes quote unquote all electronic health information right so we issued an faq as referenced here that lays this out in writing however and i know some folks take in information differently and so what we tried to do and and i think some of it was spurred by what we saw was happening in the industry too and just again um uh maybe a little bit of um misconceptions too uh we tried to portray this information uh in an infographic so without further ado we could probably move to the next slide okay so um hopefully this is helpful for you for everybody to get their head wrapped around what we're talking about when we're talking about um ehi and particularly you know this limited time frame of uscdi and then what all really is uh come uh 6 2022.
and this kind of goes back to what i've been trying to say about you know draft clinical notes and you know the focus on that or progress note ultimately it will become what would be included in the designated record set so what electronic information would be included in the designated record set and the key factor to that is what you see on your screen about designated record sets and that is whether uh those information information is used in whole or part to make a decision about individuals so taking a step back however you characterize that note if it's used to make a decision about an individual it's going to be part of the designated record set similarly a draft clinical note may normally not be part of the designated regular set but if you made a clinical decision before you finalize the note based on whatever you had in that that note which maybe if it's even test results for example um then it would become part of the part of the record uh another thing i really want to emphasize here is the wood from the ehi would be in the designated record set so what that means for covered entities and business associate is there needs to be strong communication in terms of what would be included in the designated record so that business associate also knows what information they're going to have to make available as as ehi so i wanted to point that out as well and hopefully this way the way this information is presented will be helpful we're actually going to make a fact sheet available uh soon um that will um you'll be able to have uh to reference is as well so okay thanks mike so we've talked we've talked about the exceptions and we've talked about um a more broader definition of electronic health information so i i'd like to ask you a couple of questions to hopefully clear up some misconceptions first of all does this information blocking regulation apply if a patient never requests his or her electronic health information in other words do patients have to ask for this information before any of this applies to me or other doctors so and yet they don't so the answer is um no in that regard and i felt like we got a lot of questions after one faq you know what to request and what we really wanted to emphasize to everyone is um you there doesn't have to be a request and this again is elaborated on the faq referenced here and it's on our website um you don't need a request to essentially initiate a claim of information blocking or for there even to be a potential um information blocking um so it's really focused on the practices and whether that and that practice can be an active or an omission as well so it's not just affirmative actions um it can be omissions and there's an example in the the statute of where if you just designed your health i.t in certain ways that could be information blocking or if you implement it also an example given the faq also from the statute if you implement it in ways that restricted access exchanger use that could be information block and we also gave another example in the faq about a contract provision that could materially discourage access exchange of use all those could rise to levels and interference and thus be information blocking and there wouldn't be a quote unquote request in that circumstance so um i want folks to keep that in mind also want them to keep in mind that omissions uh can be potentially information implicate the information blocking regulation so failure to exchange in certain circumstances uh not complying with another law that requires access exchange and use are all examples of potential um potentially implicating the information blocking regulation got it so uh kind of along the same lines do do physicians hospitals etc have to make ehi available through say a patient portal or other means as soon as it's created in other words do we have to be proactive about providing this information so um what i can tell you today uh is that and this is again in that uh faq which is really a revised one of a pre or prior version which is that there is no proactive um regulatory concept there's nothing codified in our regulations that requires um quote unquote something proactive to occur again um and i don't know if this provides any solace but um they they're focused on the information regulations they're focused on whether practice constitutes information blocking and whether really does it interfere with prevent or materially discourage access exchanger use so i think what we we noted in that faq is what we tried to do is give some more specific guidance through a different faq is one we issued back in march which explained where delay in making ehi available through a patient portal or an api could constitute an interference and thus implicate the information blocking regulations so hopefully that has been uh helpful to to our stakeholders and actors it is so um what i'd like to do just for a minute here is uh walk away a little bit from the discussion of the exceptions and the health information and some of the misconceptions and just try to remind everybody where the regulation came from and what its intent is you know my understanding is that congress drafted the regulation and onc implemented it really because of what we were hearing from stakeholders in the market that the basic idea is that the patient owns their own information and i think the legislation and correct me if i'm wrong mike but i think the legislation and the regulation wanted to make sure that patients could own and control their information in an unencumbered fashion um and you know we believe and i i think there's a good deal of literature that uh has demonstrated that uh patients controlling their information has a lot of benefits the first obvious is that first set of bullet points is patient engagement there's data that suggests that patients have improved outcomes when they get access to their information patients can also serve as the last line of defense hopefully we will see fewer you know missed results that weren't communicated and that sort of thing that's that can be very challenging certainly for radiologists but for all doctors um there's also pretty good evidence that information sharing supports care coordination and in terms of making doctors lives better we hope that we get to a future where um there's no more having to hunt down medical records and no more having to unnecessarily repeat tests finally excuse me um there's some public health benefits as we know right now in order to be compliant with many cms quality programs we have to report on quality metrics every year we're envisioning a future in which this can be done in an automatic fashion out of an ehr it would also be nice to be able to find out from ehrs if say an infectious disease is spreading in a certain way around the country uh the more liquid the data is uh the more benefits that both physicians and patients and the public health establishment can have um it's our hope that liquidity will create an economy of technology that both improves patients health and uh makes md's life easier i mean um i'm i'm thinking about uh better user interfaces to existing ehrs or um we've already seen with the remote monitoring of pacers that new modes of treatment and new modes of patient engagement have come online and are paid for so we're hoping that with the information sharing regulations that this uh continues a pace um it's worth noting that uh this year we're on pace for uh venture funding to reach over 30 billion dollars into digital health that's about the same level that internet funding was in 1999 so we're very helpful anyway mike i'm going to turn it back over to you to talk a little bit about uh how to report information blocking yeah thanks tom and we're we're in the home stretch now so um we just wanted to show you the uh essentially the user interface on our website and there's links in in the last slide how to get here but if you wanted to ask a question about information blocking other topics and definitely if you wanted to report information blocking you want to go here on our our health it feedback and inquiry portal so let's move to the next slide to talk a little bit about the claims process on an on information blocking claim so this is uh might be a little hard to see on this slide and we've issued it as a fact sheet so you can grab it from our website but it really shows you what happens to the com that claim when it comes in uh and really what we're doing is assessment based generally on what was provided by the uh the submitter on trying to determine who the subject of the claim is and based on who the subject is you can see the scope of authority which always falls with oig uh pretty much in all instances except for if it's a developer under the program so hopefully this will also be helpful to folks to to understand we have also have another one about you know how the claim gets processed so um when you get notification and so forth on our website so hopefully that is also helping those who are submitting claims of information blocking to understand the process better next slide please so as i alluded to uh here's where you can find all the information many many past webinars on information blocking including a 90-minute one just on information blocking and all going through all the exceptions uh that one i referenced earlier for providers on the overview of information blocking from september 14th is also available there this one that we've done today will also be available on that same web page it'll probably take until after the same thanksgiving holiday before it goes up so just wanted to to make you aware of that but you'll be able to find it there uh there'll be and this isn't the end uh there will be many more um faqs fact sheets blogs tweets and webinars to help inform you and educate you about information blocking and to that point we can go to the last slide as a reminder i mentioned there will be an ask onc again about information sharing and that will be held on december 10th you can subscribe for our emails which tell you how to register but you can also just go directly to the website and register there so that with that concludes our presentation for today i really want to thank you all for attending on behalf of omc have a great day bye now you
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